Coadministration of Measles-rubella and Rotavirus Vaccines

This study has been completed.

Sponsor:

PATH

ClinicalTrials.gov Identifier:

NCT01700621

First Posted: October 4, 2012

Last Update Posted: May 7, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.

Immediate reactogenicity, solicited adverse events (diarrhea, fever, vomiting, loss of appetite, irritability, intussusception), and all serious adverse events will be recorded from time of vaccination through Day 56 post vaccination

receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age

Biological: Rotarix vaccine

one 1.0 ml dose of oral rotavirus vaccine at 9 months of age

Other Name: rotavirus vaccine

Biological: measles-rubella vaccine

one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine

Other Name: Measels and Rubella Virus Vaccine Live USP

Active Comparator: measles-rubella vaccine

receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age

Biological: measles-rubella vaccine

one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine

Other Name: Measels and Rubella Virus Vaccine Live USP

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

9 Months to 11 Months (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Child 9 months of age eligible for measles-rubella vaccination

documented evidence of a primary rotavirus vaccine series with first dose between 6 and 10 weeks of age and second dose at least 4 weeks after first dose

healthy infants free of chronic or serious medical condition as determined by history and physical examination at time of study enrollment

parents/guardians of each participant are able to understand and follow study procedures and agree to participate in study by providing signed informed consent

Exclusion Criteria:

hypersensitivity to any component of measles-rubella or Rotarix vaccine which would preclude administration of the vaccine

history of intussusception, intestinal malformations, or abdominal surgery

known history of measles and/or rubella disease

history of previous receipt of measles and/or rubella vaccine

use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth or anticipated during study period

current enrolment in any other intervention trial or use of any investigational drug or vaccine throughout the study period

any participant who reports planning to leave teh study area before the completion of the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700621